Follow-up in Pediatric Intensive Care Unit

NCT06363344 | Unknown

• 2 other identifiers: APHP231022IDRCB: 2023-A00660-45
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Background In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and thus, most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological, social and/or physical disorders) associated with their intensive care stay. Currently in France, there are no recommendations for the management of these patients and most of them do not have standardized follow-up. Objectives Main objective: To assess the feasibility of implementing systematic and comprehensive management of pediatric patients who have been admitted to the PICU. Intermediate objectives are to study:

• The needs of the children and their families which should be met by this management
• The acceptability of this organizational innovation for all the actors involved
• The cooperation between actors of the hospital and city health system + social professionals involved
• The costs of implementation and the budgetary impact of such a system Methods Needs assessment: questionnaires and interviews with patients and their families (parents and possibly siblings if involved) to collect the medico-psycho-social impact of the PICU stay at the time of discharge and 3 months later. Study of acceptability: quantitative survey of health professionals involved in the care of these children and expected care modalities. This includes pediatric intensivists, professionals from the children's usual care services (if applicable), attending physician. Study of cooperation: analysis of needs and of the network usually solicited for the children benefiting from this care: who is identified, who remains to be identified, obstacles. Quantitative analysis of consultation reports and survey of professionals. Budgetary impact analysis: study of the cost of setting up consultations for the health care system, and study of its financial and health consequences for the main needs identified, on the basis of data from the literature and expert opinions Perspectives Compare the benefit of this systematic, multi professional and comprehensive management of pediatric patients after PICU discharge versus standard of care

Conditions

Intensive Care Psychosis

Keywords

pediatrics; tertiary prevention; resuscitation; hospital organizational innovations; coordination

Outcome Measures

Primary Outcomes (1)

• Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012)

  24 months

Secondary Outcomes (3)

• Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire

  24 months

• Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire

  24 months

• Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire

  24 months

Study Arms (1)

multi professional and comprehensive management of patients

OTHER

An advanced practice nurse who is a member of the PICU team monitors patients. Contact with children and their family is established shortly before leaving intensive care, and the child and his family are seen again few days after by the nurse where the child was discharged, then closely in the 3 months following discharge (at 1 and 3 months).

Other: Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999)

Interventions

Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999) OTHER

An advanced practice nurse who is a member of the PICU team monitors patients by questionnaires at 1 and 3 months. Depending on the anomalies detected, whether at the somatic, psychological, emotional or social level, the nurse refers to competent specialists and collaborators and continues monitoring of the family as needed.

multi professional and comprehensive management of patients

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All children discharged alive from the paediatric intensive care unit
• Hospitalized in paediatric intensive care unit for 3 days or more
• Parents and children agreeing to follow-up by the advanced practice nurse

You may not qualify if:

• Impromptu transfers (making it impossible to collect information the day before discharge) or death
• Intellectual retardation of child/parent preventing data collection by questionnaire
• Participant unable or unwilling to comply with study procedures (including those unable to speak French; those unable to honor a follow-up consultation within 3 months)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

RECRUITING

MeSH Terms

Interventions

Patient Health Questionnaire

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michaël LEVY

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaël LEVY, MD, PhD

CONTACT

+33.1.40.03.40.98; michael.levy@aphp.fr

Enora LE ROUX, PhD

CONTACT

+33.1.40.03.23.66; enora.leroux@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: April 12, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-01

Locations

FR (1)